Reducing Plasma Glucose Effect of Cinnamon in Type 2 Diabetic Patients in the Municipality of Comasagua

NCT03711682 | Completed Phase 2 DMC

• 1 other identifier: 07-2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is evaluate the effect of cinnamon powder (Cinnamomum verum) on the glycaemia and HbA1c (Glycohemoglobin) of type 2 diabetic Salvadoran patients, whose hypoglycemic treatment is only Metformin. To carry out this objective, subjects who agree to be part of the study will subjected to measurements of their body weight, height, body mass index, waist circumference, systolic pressure, diastolic pressure, capillary glucose (with glucose meter) every 2 weeks, and their glycohemoglobin (HbA1c) at the beginning and at the end of the study.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; Glucose; Cinnamomum verum; Cinnamomum zeylanicum; Cinnamon; HbA1c; Blood Pressure; Glycated Hemoglobin; Diastolic Pressure; Systolic Pressure; Body Mass Index; BMI; Metformin; Waist Circumference

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Week 0 and 12

Secondary Outcomes (5)

• Change in Capillary Glucose

  Week 0, 2, 4, 6, 8, 10, 12

• Change in Body Mass Index (BMI)

  Week 0, 2, 4, 6, 8, 10, 12

• Change in Waist Circumference

  Week 0, 2, 4, 6, 8, 10, 12

• Change in Diastolic pressure

  Week 0, 2, 4, 6, 8, 10, 12

• Change in Systolic Pressure

  Week 0, 2, 4, 6, 8, 10, 12

Other Outcomes (1)

• Change in Theoretical HbA1c

  Week 0, 4, 8, 12

Study Arms (2)

Cinnamon (Intervented)

EXPERIMENTAL

Dietary Supplement: Cinnamon

Wheat Flour (Placebo)

PLACEBO COMPARATOR

Dietary Supplement: Wheat Flour

Interventions

Cinnamon DIETARY_SUPPLEMENT

Participants in this group will receive cinnamon capsules for 12 weeks period. With a 2 g dose in capsules with 500 mg of cinnamon powder (Cinnamomum verum), 1 g in during the breakfast (2 capsules) and the other 1 g (2 capsules) during the dinner.

Also known as: Intervened, Group A

Cinnamon (Intervented)

Wheat Flour DIETARY_SUPPLEMENT

Participants in this group will receive placebo capsules for 12 weeks period. With a 2 g dose in capsules with 500 mg of wheat flour(fortified with iron, niacin, thiamin, riboflavin and folic acid), 1 g in during the breakfast (2 capsules) and the other 1 g (2 capsules) during the dinner.

Also known as: Placebo, Group B

Wheat Flour (Placebo)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Type 2 Diabetes mellitus.
• Treated only with Metformin as unique treatment for diabetes.

You may not qualify if:

• Hypersensitivity or allergy reported to Cinnamomum spp. or Peruvian balm.
• Ulcer of gastrointestinal location.
• Chronic treatment with analgesics, antibiotics, estrogens, antineoplastics, antihypertensives of the beta-blocker type, anti-inflammatory, medications whose route of action is Gamma-Aminobutyric Acid and / or anticoagulants.
• Under treatment with steroid and / or aspirin.
• Subject that use alternative medicine treatments.
• Women of childbearing age who do not use any contraceptive method.
• Subjects subjected to surgical procedures in the 6 weeks prior to the beginning of the study.
• Subjects who presented fasting glycemia levels greater than 400 mg/dL in the previous control.
• Allergies to wheat and/or diagnosed with celiac disease.
• Adverse Drug Reaction during the study.
• Subjects whose treatment schedule changed during the study intervention.
• Subjects that does not accept to be part of the study, decides to leave the study or does not have adherence to the treatment provided.

Sponsors & Collaborators

• Universidad Dr. José Matías Delgado: lead
• Hospital Nacional Rosales: collaborator
• Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua): collaborator
• Asociación Salvadoreña de Diabetes (ASADI): collaborator

Study Sites (1)

Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)

Comasagua, La Libertad Department, 0504, El Salvador

Location

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Related Links

• FDA - Substances Generally Recognized as Safe, Cinnamon bark, Ceylon.
• FDA - Compliance Policy Guides (CPGs), CPG Sec. 525.750 Spices - Definitions, 10. Cinnamon
• Diabetes Atlas, International Federation of Diabetes
• World Health Organization. World report on diabetes 2016

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Flour

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Miguel A Padilla, M.D.

  Universidad Dr. José Matías Delgado

  PRINCIPAL INVESTIGATOR

• Ana E Centeno, M.D.

  Universidad Dr. José Matías Delgado

  PRINCIPAL INVESTIGATOR

• Melissa V Abarca, M.D.

  Universidad Dr. José Matías Delgado

  PRINCIPAL INVESTIGATOR

• Roberto W Cerritos, M.D.

  Universidad de El Salvador, Hospital Nacional Rosales

  STUDY CHAIR

• William A Hoyos, M.D.

  Universidad Dr. José Matías Delgado

  PRINCIPAL INVESTIGATOR

• Karla M Navarrete, M.D., MPh.

  Secretaría Antidrogas de la Ciudad de San Salvador

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: March 1, 2018
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)